Laparoscopic Ventral Hernia Repair With Elastomeric Pain Pump
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ClinicalTrials.gov Identifier: NCT00472134 |
Recruitment Status :
Completed
First Posted : May 11, 2007
Last Update Posted : June 8, 2015
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The purpose of this study is to determine the effects of a local anesthetic dispensed via a tiny catheter device, called the ON-Q PainBuster pump, placed during surgery on top of the mesh used in the laparoscopic repair of ventral hernias. The goals are:
- reducing postoperative pain from this procedure
- decreasing length of hospital stay
- reducing or eliminating amount of post-operative narcotics used
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hernia, Ventral | Drug: bupivacaine Device: On-Q PainBuster pump | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Prospective, Randomized, Double-blind Trial of Continuous Infusion of 0.5% Bupivacaine be Elastomeric Pump for Prospective Pain Management After Laparoscopic Ventral Hernia Repair. |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Bupivicaine via Elastomeric pump
Bupivicaine via elastomeric pump
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Drug: bupivacaine
administered locally, 0.5% Bupivacaine (Marcaine Abbott Laboratories) or saline administered continuously for 48 hours at 2 mL/h.
Other Name: Marcaine |
Placebo Comparator: Placebo via elastomeric pump
Placebo via elastomeric pump
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Device: On-Q PainBuster pump
local anesthetic (bupivacaine) administered via a pain relief system consisting of a 20 gauge soaker catheter attached to an elastomeric balloon pump that is capable of infusing a set volume of local anesthetic over a wide area of surgical site for 2 to 5 days |
- Place an elastomeric infusion catheter superficial to the mesh at the conclusion of the laparoscopic ventral hernia repair and compare the following to a group that receives a placebo infusion of saline: [ Time Frame: 3 months ]
- Measuring: Visual Analog Pain Scale, Short-Form McGill Pain Questionnaire, Present Pain Intensity, Quantity of narcotic consumption [ Time Frame: 3 months ]
- Assess differences in postoperative pulmonary mechanics between the treated and nontreated groups by measuring the changes in maximal inspiratory volumes from baseline. [ Time Frame: 3 months ]
- The return of bowel function: Day of Flatus, Tolerating Regular Diet, Length of hospital stay [ Time Frame: 1 week ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Laparoscopic ventral hernia repair
- Consent obtained
Exclusion Criteria:
- Under 18 years
- Allergic to Bupivacaine
- significant liver or renal disease
- Contraindication to PCA
- Current daily opioid usage
- History of substance abuse disorders
- Dx of chronic pain syndrome
- Daily usage of NSAIDs or COX 2 inhibitors

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472134
United States, Ohio | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Michael J. Rosen, MD | University Hospitals Cleveland Medical Center |
Responsible Party: | Michael J. Rosen, MD., Principal Investigator, University Hospitals Cleveland Medical Center |
ClinicalTrials.gov Identifier: | NCT00472134 |
Other Study ID Numbers: |
11-05-22 |
First Posted: | May 11, 2007 Key Record Dates |
Last Update Posted: | June 8, 2015 |
Last Verified: | January 2012 |
Hernia Ventral Laparoscopic Hernia Repair |
Hernia Hernia, Ventral Pathological Conditions, Anatomical Hernia, Abdominal Bupivacaine Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |